CEU Credits: 0.1
Course Code: ELM-303
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/16/2021
Curriculum for this course
Overview
ISO, ICH and the FDA
Program organization
Program objectives
Definition of a medical device
Class I, II and III
Intended use
21 CFR 820 Timeline
1906 - The Jungle
1937 - Massengil Company
1957 - Thalidomide
1971 - Dalcon Corporation
1990 - FDA device recall report
A regulatory evolution
Course introduction
Introduction to design controls – Sec 820.30 (a)
Lifecycle approach
Marketing requirements
Feasibility
Documentation
Design and development planning – Sec 820.30 (b)
Goals and objectives
Task breakdown
Over optimistic schedule
Design input – Sec 820.30 (c)
User needs
Design input requirements
Unambiguous requirements
Complex products
Design output – Sec 820.30 (d)
Design review – Sec 820.30 (e)
Collection of reviewers
Systematic process
Design verification – Sec 820.30 (f)
Verification studies
Design validation – Sec 820.30 (g)
Validation plan
Clinical evaluations
Not a single document
Design transfer – Sec 820.30 (h)
Design changes – Sec 820.30 (i)
Change control process
Change levels
Design history file – Sec 820.30 (i)
Device master record
Design control conclusions
Conclusion
Final Exam
Minor update: Typographical error fixed and course updated to modernize the course design.
V1.1
